Lansinoh 53351

GUDID 60044677533517

The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.

LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI

Breast pump, electric
Primary Device ID60044677533517
NIH Device Record Key8888972f-2220-4c62-b311-c1f4a34431c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLansinoh
Version Model NumberSmartpump 3.0 Double Electric Breast Pump
Catalog Number53351
Company DUNS502960539
Company NameLANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100044677533515 [Primary]
GS160044677533517 [Package]
Contains: 00044677533515
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-11
Device Publish Date2023-07-03

On-Brand Devices [Lansinoh ]

60044677533517The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman fo
00044677537506The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman fo

Trademark Results [Lansinoh]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LANSINOH
LANSINOH
90260188 not registered Live/Pending
Lansinoh Laboratories, Inc.
2020-10-16
LANSINOH
LANSINOH
88634714 not registered Live/Pending
Lansinoh Laboratories, Inc.
2019-09-27
LANSINOH
LANSINOH
88634709 not registered Live/Pending
Lansinoh Laboratories, Inc.
2019-09-27
LANSINOH
LANSINOH
88021003 not registered Live/Pending
LANSINOH LABORATORIES, INC.
2018-06-29
LANSINOH
LANSINOH
86892456 5036258 Live/Registered
Lansinoh Laboratories, Inc.
2016-01-31
LANSINOH
LANSINOH
78846477 3272084 Dead/Expired
Lansinoh Laboratories, Inc.
2006-03-27
LANSINOH
LANSINOH
76075580 2665192 Live/Registered
LANSINOH LABORATORIES, INC.
2000-06-22
LANSINOH
LANSINOH
75492496 2337355 Live/Registered
LANSINOH LABORATORIES, INC.
1998-05-22
LANSINOH
LANSINOH
74245517 1726918 Live/Registered
LANSINOH LABORATORIES, INC.
1992-02-11
LANSINOH
LANSINOH
73823722 1599117 Live/Registered
LANOCARE LABORATORIES
1989-09-01

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